# FDA 483 - NATCO Pharma Limited - October 18, 2023

Source: https://www.keypedia.com/records/483/natco-pharma-limited/692230d1-0594-4320-ba99-2ef453417bd4

> FDA 483 for NATCO Pharma Limited on October 18, 2023. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NATCO Pharma Limited
- Inspection Date: 2023-10-18
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: This FDA Form 483 details multiple observations from an inspection, primarily concerning equipment cleaning, quality control, data integrity, and aseptic processing.

**Observation 1:** Equipment and utensils are not cleaned and maintained to prevent contamination.
*   Non-dedicated equipment (ID: VS/034) used for potent drug products showed thick build-up of materials, even when in "CLEANED" status. Swab samples revealed drug substances up to 800 times the acceptance limit, indicating cross-contamination risk. Unknown peaks were also present.
*   Another piece of equipment (ID: T/020) also showed material build-up in "CLEANED" status, with swab samples revealing drug substances up to 117 times the acceptance limit.
*   Field Alerts were reported for several tablets due to potential cross-contamination.
*   Impact assessments for cleaning and new equipment installation were inadequate, with a delayed Field Alert submission (over nine months).
*   Standard Test Procedures (STPs) for swab sample analysis are deficient, lacking mention of swab blank solution preparation (73 out of [REDACTED] STPs), type of swab stick (31 out of [REDACTED] STPs), and stability of swab samples/solutions (9 products, 25 STPs).
*   Insufficient "correct" swab sticks were available for 41 out of [REDACTED] drug products.

## Related Documents

- [483 - 2017-01-24](https://www.keypedia.com/records/483/natco-pharma-limited/2a205475-5923-4695-9193-3ade2ddbebb2)
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## Related Officers

- [Saleem A. Akhtar](https://www.keypedia.com/people/saleem-a-akhtar/1ea49212-bea5-4d43-bd0a-cdede4d3b1cf)
- [Pratik S. Upadhyay](https://www.keypedia.com/people/pratik-s-upadhyay/22ff2e0b-17d4-4c91-a3f0-c7e30b7a115b)

Company: https://www.keypedia.com/companies/natco-pharma-limited/4c97e2d8-0023-4572-966f-d396e8fecc05

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c